Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise

Effects of Different Masks on Metabolic Parameters, Inspiratory Muscle Strength and Perceived Effort During Low Intensity Aerobic Exercise

The purpose of this study will be to assess the effects of the use of masks on inspiratory muscle strength, metabolic parameters, heart rate, subjective perception of effort and the sensation of dyspnea before, during and after an aerobic test of 30 minutes long and a fixed load at lactate threshold. A randomized study of repeated measures will be carried out. A total sample of 35 active participants will be recruited. All participants will carried out a lactate threshold test and then 3 visits to the laboratory (separated at least 48 hours from each other) in order to perform 3 test of 30 minutes long without mask, with a surgical mask or with a FFP2 respirator (in a randomized order) at an intensity around lactate threshold intensity. Maximal inspiratory pressure, oxygen saturation, heart rate, blood lactate concentration, subjective perception of effort and dyspnea will be assessed before, during and after the 3 fixed intensity tests.

Study Overview

• Status: Completed
• Conditions: Masks
• Intervention / Treatment: Diagnostic test: steady intensity aerobic test of 30 minutes long

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Universidad Francisco de Vitoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• carrying out at least 2 days of physical activity per week

Exclusion Criteria:

• cardiac disease
• pulmonary disease
• chronic inflammatory disease
• sedentary behaviour

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Use of FFP2 respirator; Using of FFP2 respirator during the 30 minutes test	Diagnostic test: steady intensity aerobic test of 30 minutes long; the use of different type of masks during an aerobic exercise
Active Comparator: Use of surgical mask; Using of surgical mask during the 30 minutes test	Diagnostic test: steady intensity aerobic test of 30 minutes long; the use of different type of masks during an aerobic exercise
Sham Comparator: no mask; The 30 minutes test will be carried out without mask	Diagnostic test: steady intensity aerobic test of 30 minutes long; the use of different type of masks during an aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory muscle strength	Inspiratory muscle strength will be measured in mmHg with a Power-breathe device	change from baseline inspiratory muscle strength after the 30 minutes test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lactate concentrations	lactate concentration will be measured in mmol/L with a Lactate Pro 2 device	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
oxygen saturation	oxygen saturation will be measured in %	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
heart rate	heart rate will be measured in beats per minute with a polar H10 device	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
rate of perceived effort	rate of perceived effort will be obtained through the Borg´ scale	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
sensation of dyspnea	sensation of dyspnea will be obtained through a visual analog scale from 0 to 10 points	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test

Collaborators and Investigators

• Sponsor: Universidad Francisco de Vitoria

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: UFV_20/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No